Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients

PHASE4CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Chronic Renal Failure
Interventions
DRUG

Everolimus

One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL)

DRUG

Tacrolimus (FK506)

Capsules 0.5 mg, 1 mg. Dosing according to blood level.

DRUG

Basiliximab

One vial containing 20 mg lyophilisate. 2 x 20 mg \[day 0 (2 hrs prior to Tx) and day 4 post Tx\] to be applied as 10 sec. bolus injection, i.v.

DRUG

Enteric Coated Mycophenolate Sodium (EC-MPS)

One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day)

DRUG

Corticosteroids

Used according to Israeli standards. A minimum dose of 5mg \[prednisone, or equivalent, was used throughout the study period.

Trial Locations (3)

31096

Novartis Investigative Site, Haifa

49100

Novartis Investigative Site, Petah Tikva

64239

Novartis Investigative Site, Tel Aviv

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY